Update from the - PowerPoint Presentation

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Update from the Global Malaria Programme

Silvia Schwarte

Diagnosis, Treatment and Vaccines Global Malaria Programme e-mail: schwartes@who.int

Interagency Pharmaceutical Coordination Group Meeting18-19 June 2015UNICEF SD, Copenhagen, DenmarkSlide2

OutlineGlobal Technical Strategy WHO Guidelines for the Treatment of Malaria: 3rd EditionPrimaquine

- Transmission blocking:

Single low-dose primaquine in P. falciparum malaria - Relapse prevention: Primaquine in P. vivax / P. ovale malaria (G6PD status!) - Evidence Review Group meeting on G6PD point of care testsAntimalarial medicines - Sourcing of quality-assured products - SMC SPAQ supply shortage

Vaccine RTS,S/AS01Slide3

Since 2000, substantial progress achievedMalaria case incidence has been reduced by 30% globally20002013

Malaria mortality rates have decreased by 47% worldwide

~50 for 100 000 person at risk~25 for 100 000 person at risk~13 000 per 100 000 persons at risk~9 000

per 100 000 person at riskIncidence rateMortality rateSlide4

Global Technical Strategy Calls for an acceleration of efforts and a shift on strategic prioritiesAmbitious goals callingfor an acceleration of efforts

Strategic framework increasing focuson elimination and surveillance

202020252030Reduce malaria mortality rates vs. 2015≥40%≥75%≥90%Reduce malaria case incidence vs. 2015≥40%≥75%≥90%

Eliminate malaria from countries≥ 10countries≥ 20countries≥ 35countriesPrevent re-establishment in all malaria-freecountriesPre-ventedPre-ventedPre-vented

3 key pillars

2 supporting elements

Ensure universal access to malaria prevention, diagnosis and treatment

Accelerate efforts towards elimination and attainment of malaria-free statusTransform malaria surveillance into a core intervention

Harnessing innovation and expanding research

Strengthening the enabling environment

http://www.who.int/malaria/areas/global_technical_strategy/draft_strategy/en/Slide5

WHO Guidelines for the Treatment of Malaria 3rd Edition released on World Malaria Day 2015

http://www.who.int/malaria/publications/atoz/9789241549127/en/Slide6

WHO Guidelines for the Treatment of Malaria What's new? (1)PreventionIPTp-SP: Intermittent preventive treatment in pregnancy with at

least three doses of sulfadoxine-pyrimethamine (SP) IPTi

: Intermittent preventive treatment in infants with SP together with DPT vaccinationSMC: Seasonal malaria chemoprevention with SP + AQ in areas with highly seasonal transmissionPrimaquine (PQ)P. falciparum (Pf): Single low dose of PQ to reduce the trans-missibility of Pf infectionsP.vivax

(Pv) / P. ovale (Po): Recommendations for treating G6PD deficient patients with weekly PQ dose to prevent relapse in Pv or Po malaria under medical supervision DPT – diphtheria, pertussis, tetanus G6PD – Glucose-6-phosphate dehydrogenaseSlide7

WHO Guidelines for the Treatment of Malaria What's new? (2)Uncomplicated Pf malariaRevised dose recommendation for dihydroartemisinin +

piperaquine in young children (< 25kg body weight)Close monitoring of people with Pf

hyperparasitemia presenting with uncomplicated malariaSevere malariaRevised dose recommendation for parenteral artesunate (AS) in young children (< 20kg body weight)Recommendation for pre-referral rectal AS limited to children <6 years of ageMedicines' formulationRecommended use of fixed-dose combinations and paedi-atric

solid formulationsSlide8

Single-dose primaquine as gametocytocide in P. falciparum malaria

Single dose of primaquine at 0.25mg base/kg:

is effective in transmission blocking is unlikely to cause serious toxicity in subjects with any of the G6PD variants In low transmission areas, a single 0.25 mg base/kg primaquine dose should be given to all patients with parasitologically-confirmed P. falciparum malaria on the first day of treatment in addition to an ACT, except for pregnant women, breastfeeding women in the first six

months and children less than six months of age due to insufficient data on the safety of its use in these categories. G6PD testing is not required. http://www.who.int/malaria/pq_updated_policy_recommendation_en_102012.pdf?ua=1 Slide9

Primaquine to prevent relapse in P. vivax or P.

ovale

malariaThe G6PD status of patients should be used to guide the administration of primaquine for relapse preventionWhere status is unknown and G6PD testing is unavailable, the decision to prescribe primaquine must be based on an assessment of the risks and benefits of treating versus not treatingTo prevent future relapse, treat people with P. vivax or P. ovale malaria (excluding

people with G6PD deficiency, pregnant, infants aged <6months, women breast-feeding infants < 6 months of age) with a 14-day course (0.25-0.5mg/kg daily) of primaquine in all transmission settings. In people with moderate G6PD deficiency, consider relapse prevention with primaquine 0.75 mg base/kg once a week for 8 weeks under close medical supervision. In women who are pregnant or breastfeeding, consider

weekly chemo-prophylaxis with chloroquine until delivery and breastfeeding is com-

plete,

then treat with

14 days of primaquine to prevent future relapse. Slide10

Recommendations on G6PD testing to promote safe use of primaquine anti-relapse therapyWHO recommends that G6PD status is ascertained before administering daily primaquine ther­apy for 14 days to prevent relapses in patients with confirmed acute P.vivax or P. ovale

infection.The

introduction of point-of-care G6PD tests should proceed, with appropriate investment in quality assurance and quality control including training, supervision, behaviour change communications and close monitoring of the feasibility, acceptability and ease of use of these tests. Lessons learnt from initial small scale deployment should guide decisions to expand deployment of G6PD diagnostic services across the health care system.If G6PD status is unknown, then G6PD qualitative point-of-care tests can be deployed to identify G6PD non-deficient patients prior to prima­quine administration. Such tests should be >95% sensitive compared to spectro-photometry or equivalent quantitative tests, stable at temperatures expected in tropical settings (30–40°C) and have a negative predictive value of >95% at G6PD enzyme activity levels <30% of normal.

The specific indications and contraindications for primaquine radical cure in males and females with G6PD deficiency should follow the recommendations given in the WHO Guidelines for the Treatment of Malaria (3rd edition, 2015). Slide11

----------------------------------------------------------------------------------------------------------------------------------------------AL: artemether/lumefantrine; AS: artesunate; AQ:

amodiaquine; MQ: mefloquine;

SP: sulfadoxine/pyrimethamineWHO-prequalified medicinesLast updated 8 June 2015 – no changes since November 2014 Fixed-dose combinations

- AL, 20mg/120mg: Ajanta, Cipla, Ipca, Macleods, Mylan, Novartis, Strides - AL, 20mg/120mg, dispersibles: Ajanta, Novartis - AL,

40mg/240mg: Mylan

- ASAQ:

Ajanta, Cipla, Guilin, Ipca

,

Sanofi

- ASMQ:

DNDi

/

Cipla

Co-Blisters

(

Co-B)

- AS + AQ:

Cipla

, Guilin,

Ipca

, Strides

- AS + SP:

Guilin

Injectables

-

AS powder for

injection (30mg, 60mg, 120mg):

Guilin

Full list of WHO-

prequalifed

medicines available at:

http

://apps.who.int/prequal

/

Eurartesim

(DHA-PPQ)

(

Uncomplicated

Pf

malaria

) – EMA

approval

Rectal AS

(Pre-referral treatment of

severe malaria in children < 6 years

)

PQ

(

Pf

transmission blocking and

Pv/Po

relapse prevention)

SP

(Intermittent Preventive Treatment

in pregnancy and during infancy)

SP+AQ

(Seasonal Malaria

Chemo-

prevention

)Slide12

PQ and SP sourcing for procurement(last updated 8 June 2015)LIST OF MALARIA PHARMACEUTICAL PRODUCTS classified according to the Global Fund Quality Assurance Policy (Version 76 reviewed, April 2015)

http://www.theglobalfund.org/documents/psm/PSM_ProductsMALARIA_List_en/

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Seasonal Malaria Chemoprevention (SMC) Medicine shortage: sulfadoxine-pyrimethamine (SP) + amodiaquine (AQ)

IEC – Information, education and communication

Single-source supplier for quality-assured co-blistered SP+AQ: WHO PQ: SP+AQ (500/ 25 mg + 150 mg), GF ERP: SP+AQ (250/12.5 mg + 75 mg)Target area: Highly seasonal

malaria transmission across the Sahel sub-region Target population: A complete SP+AQ treatment course should be given to children aged 3 and 59 months, at monthly intervals beginning at the start of the transmission season, up to a maximum of four doses

during the malaria transmission season.

Prioritization:

WHO strongly encourages prioritization of communities that have implemented SMC in the years 2013 and 2014 for continuation in 2015.Interim measure:

Procurement and distribution of separate blisters / loose tablets; training, IEC materials, etc.

Impact monitoring!

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4

th set of results on RTS,S/AS01 released Effect of booster dose and longer-term follow up to an average of four years per child from vaccination Efficacy is short-lived – booster dose required. Clinical malaria: Overall efficacy with booster dose in 6-12 weeks and 5-17 months old children at 26% and 36%, respectively, over full duration of trial.Severe malaria:

Without booster dose, no protection in both age groups, as cases averted in the first 18 months were shifted to older age groups as efficacy wanes. With booster: Overall efficacy in 5-17 months old children at 32%. European Medicines Agency is currently reviewing under Article 58 – only in case of a "positive scientific opinion" WHO will convene the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) to assess a potential policy recommendation. RTS,S/AS01 would be evaluated as a possible addition to – not a replacement for – existing prevention, diagnostic and treatment measures.http://www.who.int/immunization/research/development/malaria_vaccine_qa/en/Slide15

Thank youSlide16

Backup slidesSlide17

ACT deliveries (2005-2013) by combinationSlide18

ACT deliveries (2005-2013) Fixed-dose combinations versus co-blistersSlide19

ACT versus RDT delivery / sales trends (2005-2013)